Remifentanil Tapering and Post-adenotonsillectomy Pain in Children: a Randomised, Placebo Controlled, Double Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Intravenous fentanyl consumption in the perioperative period (mcg/kg).
研究概览
简要总结
Tonsillectomy is the commonest operation of childhood and results in considerable pain.
Remifentanil is a potent, ultra short acting opioid with a long- established safety record in paediatric anaesthesia that is used to provide intraoperative analgesia.
There is evidence from adult studies that remifentanil increases postoperative pain, although this may be ablated if propofol (rather than inhalational anaesthesia) is used or if the remifentanil is tapered rather than abruptly discontinued at the end of surgery.
The analgesic effect of gradual withdrawal of remifentanil at the end of surgery has not been studied in children and may have significant clinical implications.
The primary measure of efficacy will be the dose of fentanyl rescue analgesia in the peri-operative period (1 mcg.kg-1 bolus for >20% increase in pulse, blood pressure or movement intraoperatively or a FLACC(Face, Legs, Arms, Cry, Consolablity) score of >5 in recovery).
详细描述
Tonsillectomy is one of the commonest childhood operations in the world; approximately 9200 children have their tonsils removed every year in Norway alone.
Postoperative pain following the procedure is significant and notoriously difficult to mange. It´s management is potentially complicated by nausea and the risk of tonsillar infection or re-bleeding. Post-tonsillectomy pain in children is persistent, with 75% of children experiencing significant pain for the first three days and 50% still suffering with significant pain one week after the procedure. As well as delaying recovery, reducing oral intake of food and drink and disturbing sleep, post tonsillectomy pain has been shown to result in more than 50% of patients and their parents consulting their primary care physician in the post operative period, with the ensuing costs to the families and healthcare providers.
It is worth noting, that despite significant postoperative pain and potential complications, recovery after adeno / tonsillectomy is excellent.
The operative nature of tonsillectomy and adenotonsillectomy necessitates the provision of general anaesthesia to the child. The technique must ensure sufficient depth of anaesthesia and analgesia and protection of the airway from blood and surgical debris. Whilst there are a wide variety of anaesthetic techniques employed to achieve these goals,Total Intra Venous Anaesthesia (TIVA) with propofol and remifentanil has been shown in previous studies to be superior to volatile based (gas) anaesthesia, resulting in less post operative nausea and vomiting, less long term adverse behavioural changes, improved quality of emergence from anaesthesia, and less environmental pollution.
The use of remifentanil and propofol TIVA in children is well established and has been in use since at least the year 2000 for children undergoing tonsillectomy. Despite this the effects of remifentanil dosing on post-operative pain has not been studied in children undergoing tonsillectomy, though it may play a significant role.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Two syringes will be simultaneously infused during the operation. One will contain normal saline solution and the other remifentanil solution. Prior to the end of the operation one of the syringes will have a step wise decrease in infusion rate whilst the other will be abruptly stopped at the end of surgery.
The syringes will be prepared according to randomisation in the hospital pharmacy and the identity of each syringe will be masked from all those involved in the study. The syringe randomisation will be de-coded following completion of recruitment.
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society Anaesthesiology I-II children 1 to 10 years
- •Weight over 10.0 Kg
- •Presenting for tonsillotomy / tonsillectomy or adenotonsillectomy at Akershus Universitetssykehus, Lørenskog and Lovisenberg Diakonale Hospital, Norway
排除标准
- •Children who have had airway surgery previously.
- •Children who have had any type of surgery in the previous 12 months.
- •Children using chronic pain medication or who have used analgesia in the 24 hours preceding surgery.
- •Children who are known to suffer from NSAID sensitive asthma.
- •Children with a known allergy to propofol or remifentanil.
- •Pre-existing cardiac, renal, liver dysfunction.
- •Children or parents who are not fluent in Norwegian or English.
- •Children in whom more than three attempts at intravenous cannulation are required or in those who request an inhalational induction or premedication
研究组 & 干预措施
Remifentanil tapering / Placebo abrupt cessation
Syringe one contains Remifentanil 2 mg in 40 ml NaCl 9 mg.ml-1 = 50 µg.ml-1 which will be infused at a rate of 0.9 µg.kg-1.min-1 and Syringe two contains 40 ml NaCl 9 mg.ml-1 at an identical infusion rate. According to randomisation syringe one will then be tapered towards the end of surgery and syringe two abruptly stopped.
干预措施: Remifentanil (Drug)
Remifentanil tapering / Placebo abrupt cessation
Syringe one contains Remifentanil 2 mg in 40 ml NaCl 9 mg.ml-1 = 50 µg.ml-1 which will be infused at a rate of 0.9 µg.kg-1.min-1 and Syringe two contains 40 ml NaCl 9 mg.ml-1 at an identical infusion rate. According to randomisation syringe one will then be tapered towards the end of surgery and syringe two abruptly stopped.
干预措施: Sodium Chloride 9mg/mL (Drug)
Placebo tapering / Remifentanil abrupt cessation.
Syringe one contains 40 ml NaCl 9 mg.ml-1 and Syringe two contains Remifentanil 2 mg in 40 ml NaCl 9 mg.ml-1 = 50 µg.ml-1 which will be infused at a rate of 0.9 µg.kg-1.min-1. According to randomization syringe one will be tapered towards the end of surgery and syringe two abruptly stopped.
干预措施: Remifentanil (Drug)
Placebo tapering / Remifentanil abrupt cessation.
Syringe one contains 40 ml NaCl 9 mg.ml-1 and Syringe two contains Remifentanil 2 mg in 40 ml NaCl 9 mg.ml-1 = 50 µg.ml-1 which will be infused at a rate of 0.9 µg.kg-1.min-1. According to randomization syringe one will be tapered towards the end of surgery and syringe two abruptly stopped.
干预措施: Sodium Chloride 9mg/mL (Drug)
结局指标
主要结局
Intravenous fentanyl consumption in the perioperative period (mcg/kg).
时间窗: From the induction of anaesthesia until discharge from the day case surgical unit.4 hours.
Intravenous fentanyl consumption in the perioperative period (mcg/kg).
次要结局
- Faces Legs Activity Cry Consolability (FLACC) pain scores at 20,40,60,90 and 120 minutes after the operation to give a Sum of Pain Intensity Differences (SPID).(From cessation of anaesthesia until 120 minutes after the cessation of anaesthesia.)
- Parents' Post Operative Pain Measure (PPOMP) on post operative days 1,3,7,10,14 and 28(From the cessation of anaesthesia until the 28th day following discharge from the day case surgical unit.)
研究者
William James Morton
Principle Investigator
University Hospital, Akershus